Veracuity Blog Patient trust is key to successful clinical trial recruitment Health research cannot be done without the active participation of patients, and without access to their medical records to determine the safety and efficacy of treatments. Validation of assumptions from clinical studies conducted before the drugs reache the market depends on the availability of…
DetailsVeracuity Blog Patient trust as the most precious prerequisite in health research Health research cannot be done without the active participation of patients. This especially concerns those who suffer from an incurable disease, should it be common plagues of today such as cancer, Alzheimer’s, or rare and complex disorders. Data collected for monitoring the safety…
DetailsVeracuity Blog The unbearable cost of pharmacovigilance “Making more informed drug choices using comprehensive and actionable adverse drug events data leads to improved patient safety and outcomes and reduced costs.” Becker’s Hospital Review, 2015 According to Institute of Medicine (IoM) study To Err Is Human (IoM, 2007), adverse drug events are the largest single category…
DetailsVeracuity Blog Drug diversion – issues and identification Section 505-1 of the FDCA authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS) if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks. Spotting drug diversion within the current reporting system…
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